Wellness Products: does FDA require 510k for selling wellness products?

Mangafanga

Starting to get Involved
Hello,

I am planning to sell wellness products in the US, these are fitness devices targeted towards encouraging healthy lifestyle. Do I need a 510k? If not, then what regulation of FDA do I need to follow to market my device as FDA approved?

In general, does FDA regulate wellness devices at all? I could not find much over the internet except for a FDA guidance on General wellness.

Regards
 

ChrisM

Quite Involved in Discussions
IIRC there is something about a device only needing FDA approval if it offers a "medical improvement" in the condition of the person using it. No doubt someone with more specific knowledge of the Regs will be along soon to quote the precise text, but anything that is just aimed at a person's lifestyle rather than their actual medical health is most likely not subject to FDA / 510(k) approval.

There may be other regulations and laws that apply, however.
 

Mangafanga

Starting to get Involved
IIRC there is something about a device only needing FDA approval if it offers a "medical improvement" in the condition of the person using it. No doubt someone with more specific knowledge of the Regs will be along soon to quote the precise text, but anything that is just aimed at a person's lifestyle rather than their actual medical health is most likely not subject to FDA / 510(k) approval.

There may be other regulations and laws that apply, however.
Thanks for your response Chris. My device does not fit into the definition of Medical device, my intended use is only to "encourage" healthy lifestyle/fitness and I do not claim anything else (treat/diagnose/help, etc.)
 

cosmeticqg

Starting to get Involved
I would be careful. There are many 'general wellness' products that fall under FDA's jurisdiction. For example, weight scales and massagers.
 

EmiliaBedelia

Quite Involved in Discussions
If not, then what regulation of FDA do I need to follow to market my device as FDA approved?
Just to be clear, following the regulation and/or having an establishment registration does not give you the ability to market the device as "cleared" or "approved" or anything else. You can only use FDA clearance or FDA approval in marketing materials if you do actually have a clearance or approval letter.
If your product has not been reviewed by the FDA prior to marketing then the FDA has had no involvement at all with your product, and it is misbranding to imply otherwise.

For a wellness product, you should clearly state the intended use for your product. Personally I'd also include a statement like "This product is intended to promote general wellness as part of a healthy lifestyle and is not intended for diagnosis or treatment of a medical condition" or something like that as a CYA.
 

Aliken

Involved In Discussions
Hello,

I am planning to sell wellness products in the US, these are fitness devices targeted towards encouraging healthy lifestyle. Do I need a 510k? If not, then what regulation of FDA do I need to follow to market my device as FDA approved?

In general, does FDA regulate wellness devices at all? I could not find much over the internet except for a FDA guidance on General wellness.

Regards
Hello,
FDA guidance provides a lot of information.
You can't say the device is approved or cleared by the FDA, but you can write that it's a low-risk wellness product (if it complies with such an FDA definition). A few years ago, I wrote a post about wellness products (summarizing the guidance) that may be interesting for you as it also discusses possible claims

 
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